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EASi-PROTKT™: Vicadrostat with Empagliflozin for Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

This study, EASi-PROTKT™, is for adults with type 2 diabetes, high blood pressure, and cardiovascular disease, who do not have a history of heart failure. It aims to see if taking vicadrostat along with empagliflozin can help reduce the risk of heart problems. You would be randomly assigned to one of two groups: one receives vicadrostat and empagliflozin, and the other receives a placebo (an inactive substance that looks like vicadrostat) with empagliflozin. The study will measure how long it takes for participants to experience a cardiovascular death or heart failure event. The study is currently unclear on its recruitment status and plans to enroll 11,800 people.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. It plans to enroll 11,800 people.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time to first cardiovascular death or heart failure event, is measured for up to 51 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07064473

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~11,800 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:VicadrostatEmpagliflozinPlacebo matching Vicadrostat

At a glance

Recruiting sites
1103 of 1147 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
Measured over Up to 51 months

Conditions

Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases

Explore related trials

Cardiovascular DisorderHypertensionType 2 Diabetes Mellitus

Where it's being run

1147 sites across 103 states
Germany90
Japan80
China66
France42
Florida36
United Kingdom33
Italy32
Texas28

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18 years old at time of consent
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
Participants with medical history of hypertension and on active pharmacological treatment
Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
Established cardiovascular (CV) disease and on active pharmacological treatment
At least one additional risk factor for developing heart failure (HF)

Exclusion

History of HF or hospitalization for HF or treatment of HF
Atrial fibrillation or Atrial flutter with a resting heart rate \>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
Treatment with an Mineralocorticoid receptor antagonist (MRA)
Treatment with amiloride or other potassium-sparing diuretic
Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:
A direct renin inhibitor (e.g. aliskiren)
More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
Other aldosterone synthase inhibitors (e.g. baxdrostat)

What this trial measures

  • Time to first event of cardiovascular (CV) death or heart failure event (HFE)Up to 51 months